A couple of years ago the one-two punch was all the rage inprescription drug cases.  “One-two punch” has been our moniker for decisions where plaintiffs ingested only generic drugs, but tried to hedge their bets, given the threat of generic drug preemption, by also suing branded drug manufacturers on innovator liability theories alleging that innovators’ purportedly inadequate labeling could make them liable to people who never used their products. The new one-two held the generic drug claims preempted while at the same time ruling that the state in question (see our 50-state compilation) did not recognize inadequate warning claims against companies that neither sold nor profited from the sale of the drug that purportedly injured the plaintiff.  A one-two punch decision required us to update both our generic preemption and ourinnovator liability scorecards.

More recently, these cases sort of tailed off.  We assumed this was due to a litigation version of chronic traumatic encephalopathy − the plaintiffs had grown weary (and financially wary) of losing, and had stopped suing these defendants on theories that had been so widely rejected in the courts.  Apparently, though, the plaintiff in Tsavaris v. Pfizer, Inc., ___ F. Supp.3d ___, 2016 WL 80221 (S.D. Fla. Jan. 7, 2016), didn’t get the memo.  The result is another excellent one-two punch decision.

Tsavaris was one of the few (only two others on either ourinnovator liability or generic preemption scorecards) involving drugs used in hormone replacement therapy.  Although the drugs were different, the result was not.  Generic preemption thoroughly obliterated claims involving the drug that the plaintiff actually took.  2016 WL 80221, at *4-9.  The Eleventh Circuit’s decision inGuarino v. Wyeth, 719 F.3d 1245 (11th Cir. 2013) (another one-two punch case), controlled with respect to most of the claims. The most interesting aspect of the preemption ruling in Tsavariswas dismissal of a pre-approval defect/negligence case:

Plaintiff attempts to circumvent preemption by focusing on the steps that [generic defendant] could have taken prior to FDA approval. . . .  However, Plaintiff's argument that [generic defendant] could have conducted itself differently prior to FDA approval ignores the nature of a generic drug.  A generic drug must be the chemical equivalent and bioequivalent of its brand name counterpart.  If [generic defendant] altered the design of [the innovator drug], it would be designing a new drug and [generic defendant] would go through an entirely different process of approval, subject to an entirely different set of regulations. To find that Plaintiff's defective design claim is not preempted because [generic defendant] could have designed an entirely new drug, instead of manufacturing the generic version of [the innovator drug], would renderBartlett meaningless.7

7 This argument is similar to the argument that the Supreme Court rejected inBartlett. . . .  [T]he Supreme Court explicitly rejected the “stop-selling” rationale as “incompatible” with their “pre-emption jurisprudence.”  Preemption cases presume that an actor seeking to satisfy both his federal and state law obligations are not required to cease acting altogether to avoid liability.  Following this reasoning, it would not make sense for this Court to find that [generic defendant] could have complied with its state law design defect duty by selling a new drug altogether, instead of the generic version of [the innovator drug].

It would also undercut Congress' purpose in enacting the Hatch-Waxman Amendments, which was to develop the generic drug market.

Tsavaris, 2016 WL 80221, at *6 & n.7.  Tsavaris is thus the second decisive rejection of purported “pre-approval” defect/negligence claims in recent weeks.  Our post on Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) – preemption, but not involving generic drugs − which aptly described pre-approval theories as “never-start selling” claims (id.at 300), describes that other decision.  Tsavaris thus confirms our impression that “pre-approval” claims aren’t likely to be any more successful in avoiding preemption than reference listed drug, FDAAA amendments, parallel claims, stop-selling claims, or any of the other novel theories plaintiffs have tried to hide behind sincePLIVA v. Mensing, 131 S. Ct. 2567 (2011), was decided.

Tsavaris also held preempted a claim for failure to test (which Florida law doesn’t recognize as a tort theory to start with, Adams v. G.D. Searle & Co., 576 So.2d 728, 730-31 (Fla. App. 1991)), because such testing purportedly would have required adoption of a different design or different warnings, which were themselves preempted.  Tsavaris, 2016 WL 80221, at *7-8.

That’s the right jab.

The left hook dismissed innovator liability under Florida law. That’s not surprising, since our 50-state survey of innovator liability shows seven prior rejections of this benighted theory by courts applying Florida law – including the aforementioned Guarinoone-two punch affirmance.  While dismissal of innovator liability is thus not at all surprising, the language that Tsavaris used is gratifying.  The court joined “the overwhelming national consensus − including decisions of every court of appeal and the vast majority of district courts around the country to consider the question” in holding “that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of the generic form of a product.”  Tsavaris, 2016 WL 80221, at *9 (citation and quotation marks omitted).  The two contrary decisions were “clearly outliers.”  Id. at *10.

Down for the count.